Manufacturing Process Validation

2022 ◽  
pp. 224-231
Keyword(s):  
Manufacturing Process ◽  
Process Validation

Process Validation of Isoniazide and Rifampin Tablet

2021 ◽  
pp. 105-110
Author(s):  
Priyanka Kailas Borse ◽  
Kiran B. Dhamak
Keyword(s):  
Manufacturing Process ◽  
Critical Parameter ◽  
Tablet Formulation ◽  
Process Equipment ◽  
Wet Milling ◽  
Validation Data ◽  
Process Validation ◽  
Validation Criteria ◽  
Dry Mixing ◽  
High Degree

The plethora subscribed in this research is directed towards the process validation of tablet formulation containing Isoniazide and Rifampin. The different process parameters were identified and studied for the tablet formulation batches. Three process validation batches of same size, manufacturing process, equipment and validation criteria was taken. The critical parameter involved in sifting, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication and compression stages were identified and evaluated. The outcome indicated that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes.

scholarly journals Process validation: An essential process in pharmaceutical industry

2015 ◽  
Vol 1 (4) ◽  
pp. 179
Author(s):  
Brahmaiah Bonthagarala ◽  
Sandhya Ch. ◽  
Pusuluri Dharani Lakshmi Sai ◽  
Konkipudi Venkata Sivaiah
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Pharmaceutical Industry ◽  
Manufacturing Process ◽  
Iso 9000 ◽  
Pharmaceutical Manufacturing ◽  
Process Validation ◽  
The Us ◽  
Tablet Manufacturing

The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

scholarly journals Process Validation in Pharmaceutical Product Development: An Overview

2021 ◽  
Vol 10 (5) ◽  
Author(s):  
Sreenivasa.G. M ◽  
Sriranga. T ◽  
Naveen Banakar ◽  
Vaishakha Kori ◽  
Chetankumar Vasanad ◽  
...  
Keyword(s):  
Product Development ◽  
Manufacturing Process ◽  
Process Development ◽  
Pharmaceutical Product ◽  
Product Development Process ◽  
Process Validation ◽  
Pharmaceutical Product Development ◽  
Process Qualification ◽  
Evaluation Of Data ◽  
Required Quality

As per GMP process validation is very important and required part in product development. Process Validation is required for ensuring and providing the documentary evidence and also required for giving the Surety that process by which the formulation is prepared is capable of consistently producing the product of required quality and purity. A validated manufacturing process is one which has been proved to do what it purports on is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and Continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment Systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. This article gives a general introduction and overview about process validation in pharmaceutical manufacturing process and its importance. Keywords: GMP, Validation, validation manufacturing process.

scholarly journals Automated GMP-Compliant Production of [68Ga]Ga-DO3A-Tuna-2 for PET Microdosing Studies of the Glucagon Receptor in Humans

2020 ◽  
Vol 13 (8) ◽  
pp. 176
Author(s):  
Michael Wagner ◽  
Johan G. Doverfjord ◽  
Joachim Tillner ◽  
Gunnar Antoni ◽  
Torsten Haack ◽  
...  
Keyword(s):  
Manufacturing Process ◽  
Specific Binding ◽  
Radiochemical Yield ◽  
Radical Scavenger ◽  
Glucagon Receptor ◽  
Residual Solvent ◽  
Process Validation ◽  
Integrity Tests

Introduction: [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 (previously published as [68Ga]Ga-DO3A-VS-Cys40-S01-GCG) has shown high-affinity specific binding to the glucagon receptor (GCGR) in vitro and in vivo in rats and non-human primates in our previous studies, confirming the suitability of the tracer for drug development applications in humans. The manufacturing process of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was automated for clinical use to meet the radiation safety and good manufacturing practice (GMP) requirements. Methods: The automated synthesis platform (Modular-Lab PharmTrace, Eckert & Ziegler, Eurotope, Germany), disposable cassettes for 68Ga-labeling, and pharmaceutical-grade 68Ge/68Ga generator (GalliaPharm®) used in the study were purchased from Eckert & Ziegler. The parameters such as time, temperature, precursor concentration, radical scavenger, buffer concentration, and pH, as well as product purification step, were investigated and optimized. Process optimization was conducted with regard to product quality and quantity, as well as process reproducibility. The active pharmaceutical ingredient starting material DO3A-VS-Cys40-Tuna-2 (GMP-grade) was provided by Sanofi Aventis. Results: The reproducible and GMP-compliant automated production of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 with on-line documentation was developed. The non-decay-corrected radiochemical yield was 45.2 ± 2.5% (n = 3, process validation) at the end of the synthesis with a labeling synthesis duration of 38 min and a quality controlincluding release procedure of 20 min. The radiochemical purity of the product was 98.9 ± 0.6% (n = 17) with the total amount of the peptide in the preparation of 48 ± 2 µg (n = 3, process validation). Radionuclidic purity, sterility, endotoxin content, residual solvent content, and sterile filter integrity tests met the acceptance criteria. The product was stable at ambient temperature for at least 2 h. Conclusion: The fully automated GMP-compliant manufacturing process was developed and thoroughly validated. The resulting [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was used in a clinical study for accurate quantification of GCGR occupancy by a dual anti-diabetic drug in vivo in humans.

scholarly journals Process validation of sucralfate oral suspension

2021 ◽  
Vol 12 (3) ◽  
pp. 2005-2013
Author(s):  
Aluri Nandini ◽  
Ravi G
Keyword(s):  
Manufacturing Process ◽  
Oral Suspension ◽  
Process Variables ◽  
High Quality ◽  
Validation Data ◽  
Process Validation ◽  
Critical Elements ◽  
Commercial Purpose ◽  
Critical Process

Drugs are the critical elements in the health care system. They must be manufactured in the high-quality levels. End product testing by itself does not guarantee of the quality of the product. Quality assurance techniques must be used. In pharmaceutical industry, process validation performs this task, by ensuring that the process does what it purports to do. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated, we can assure that the final product is of the best quality. This study is intended to demonstrate and standardize the data that should be routinely included in the marketing authorization dossier describing evolution and validation of the manufacturing process and distinguish from the validation data which more properly fall under the remit of GMP inspection. During the study of critical process variables of sucralfate oral suspension were validated to demonstrate consistency of manufacturing process to produce the produce the product of desired quality. The validation studies were conducted which were intended for the use of commercial purpose so this validation study is concurrent type. All the in-process variables and finished product characteristics were monitored; the statistical analysis of data was carried out. Further from the results, it is inferred that the manufacturing process of sucralfate oral suspension was validated.

Identifying groups of airborne particles by ordination

1994 ◽  
Vol 52 ◽  
pp. 856-857
Author(s):  
M. Shlepr ◽  
C. M. Vicroy
Keyword(s):  
Elemental Analysis ◽  
Energy Dispersive Spectroscopy ◽  
Manufacturing Process ◽  
Spatial Representation ◽  
Airborne Particles ◽  
Common Source ◽  
Data Set ◽  
Microelectronics Industry ◽  
Induced Changes ◽  
Source Materials

The microelectronics industry is heavily tasked with minimizing contaminates at all steps of the manufacturing process. Particles are generated by physical and/or chemical fragmentation from a mothersource. The tools and macrovolumes of chemicals used for processing, the environment surrounding the process, and the circuits themselves are all potential particle sources. A first step in eliminating these contaminants is to identify their source. Elemental analysis of the particles often proves useful toward this goal, and energy dispersive spectroscopy (EDS) is a commonly used technique. However, the large variety of source materials and process induced changes in the particles often make it difficult to discern if the particles are from a common source.Ordination is commonly used in ecology to understand community relationships. This technique usespair-wise measures of similarity. Separation of the data set is based on discrimination functions. Theend product is a spatial representation of the data with the distance between points equaling the degree of dissimilarity.

Water in the Vinegar Manufacturing Process

1952 ◽  
Vol 44 (3) ◽  
pp. 449-449
Author(s):  
Rudolph Allgeier ◽  
Reuben Wisthoff ◽  
Frank Hildebrandt
Keyword(s):  
Manufacturing Process
Sign in / Sign up

Export Citation Format

Share Document